4 ARRA and HITECH Act On February 17, 2009, President Obama signed the American Recovery and Reinvestment Act (ARRA) and Health Information Technology for Economic and Clinical Health (HITECH) Act Over $60 billion in incentives and grant money to stimulate healthcare information technology (HIT) adoption First time state-based Medicaid programs and Departments of Health became major purchaser of HIT This act seeks to bolster health IT to improve the delivery of healthcare in the United States With various provisions and regulations, the Act provides financial assistance, tools, and resources to HCPs to allow for implementation and utilization of EHR Pay-for-performance (P4P) programs and other quality initiatives Confidential 2014 PDR Network, LLC. All Rights Reserved. Confidential PDR Network, LLC. All Rights Reserved. "PDR" and "Physicians' Desk Reference" are registered trademarks of PDR Network, LLC 44

5 Drivers of EHR Adoption by U.S. Providers Physician s EHR Choice: 1. Eligible professionals can be paid up to $44,000 over 5 years through Medicare and up to $63,750 over 6 years through Medicaid to adopt EHR demonstrate meaningful use Additional dollars from health plans and cost savings 2. Refuse these incentives, don t adopt EHR and suffer CMS penalties Mounting costs for quality reporting in paper Challenges in recruiting MDs or selling practice Confidential 2014 PDR Network, LLC. All Rights Reserved. Confidential PDR Network, LLC. All Rights Reserved. "PDR" and "Physicians' Desk Reference" are registered trademarks of PDR Network, LLC 55

7 Adoption of EHR Systems by Office-Based Physicians Rapid rate of adoption projected due to Meaningful Use (MU) incentives and penalties Adoption of EHRs increases with the size of the physician practice as the costs can be spread out over a larger group of people Those under age 50, 64% were adopters, while about 50% of those over age 50 were adopters Source: CDC/NCHS, National Ambulatory Medical Care Survey and National Ambulatory Medical Care Survey, EHR Survey, NCHS Data Brief, January 2014 Confidential 2014 PDR Network, LLC. All Rights Reserved. Confidential PDR Network, LLC. All Rights Reserved. "PDR" and "Physicians' Desk Reference" are registered trademarks of PDR Network, LLC 77

20 HIPAA Covered Entities Are you a 1.Healthcare provider? 2.Healthcare clearinghouse? 3.Health plan? or are you a business associate of a covered entity? Simplification/HIPAAGenInfo/Downloads/CoveredEntitycharts.pdf 20

21 Can the message stand alone? Is everything on label? Is use of product name OK? Is the approved PI attached/accessible? Is risk information in the body of the message or segregated? Have you taken account of the message delivery system? 21

22 Questions? Dale Cooke PhillyCooke on Twitter PhillyCooke.com 22

23 Speaker Bio: Dale Cooke Dale Cooke is the owner of PhillyCooke Consulting, which provides advice and training to companies about developing compliant promotional materials for FDA-regulated products. Dale has worked with more than 30 pharmaceutical and medical device clients around the world. His insights have been featured in the Wall Street Journal s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law Institute (FDLI), and the Alliance for a Stronger FDA. He also serves on the faculty of the University of California San Francisco s American Course in Drug Development and Regulatory Sciences program. Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of FDLI s primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and life sciences use of social media. Previously, Dale served as the head of Regulatory for Digitas Health LifeBrands, which is part of the Publicis Healthcare Communications Group. Dale earned his B.A. in Philosophy from Southern Methodist University, an M.A. in Analytical Philosophy from the University of Arizona, and studied Epidemiology and Biostatistics at Drexel University s School of Public Health and Healthcare Compliance at Seton Hall University s School of Law. 23

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